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Minocycline and Aspirin in the Treatment of Bipolar Depression (Minocycline)

This study has been completed.
Stanley Medical Research Institute
University of Oklahoma
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc. Identifier:
First received: September 2, 2011
Last updated: October 28, 2015
Last verified: October 2015
The purpose of this study is to determine whether Minocycline and aspirin are effective in the treatment of depression in Bipolar patients.

Condition Intervention Phase
Bipolar Disorder Depression Drug: Minocycline Drug: Aspirin Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Minocycline and Aspirin in the Treatment of Bipolar Depression

Resource links provided by NLM:

Further study details as provided by Laureate Institute for Brain Research, Inc.:

Primary Outcome Measures:
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: 6 weeks ]
    Depression symptom severity rating scale

Enrollment: 100
Study Start Date: September 2011
Study Completion Date: September 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo & Placebo
Placebo for minocycline & placebo for aspirin
Drug: placebo
placebo for minocycline and/or aspirin
Active Comparator: minocycline & aspirin
Minocycline 100mg PO BID for 6 weeks & Aspirin 81 mg PO BID for 6 weeks
Drug: Minocycline
100 mg po bid for 6 weeks
Drug: Aspirin
81 mg po bid for 6 weeks

Detailed Description:


New medication classes are needed to improve treatment effectiveness in the depressed phase of bipolar disorder (BD). Extant evidence suggests that BD is not only characterized by reduced monoaminergic signaling, but also by neural changes such as dendritic remodeling, demyelination, and glial and neuronal cell loss (73). These changes have been hypothesized to result from chronic inflammation (45), based partly on convergent evidence that proinflammatory cytokines are elevated in depressed patients with BD (34, 12). The principal aims of the proposed research is to evaluate the antidepressant efficacy in bipolar depression of minocycline, a drug with neuroprotective and immune-modulating properties, and of aspirin, at doses expected to selectively inhibit cyclooxygenase 1 (COX-1), within the context of a randomized, double-blind, placebo-controlled, parallel-group clinical trial following a 2 x 2 design.

Specific Aims Specific Aim 1: To test the hypothesis that augmentative treatment with minocycline and/ or aspirin will improve depression ratings to a greater extent than placebo.

Specific Aim 2: To investigate the relationship between the response to minocycline, aspirin and markers of inflammation (serum concentrations of IL-6 and CRP, and IL-6 mRNA expression in peripheral blood monocytes (PBM). The investigators will test the hypotheses that: a) minocycline treatment will reduce inflammation to a greater extent than placebo; b) during minocycline treatment the change in inflammatory cytokine expression will correlate with the change in depression ratings; c) the baseline elevation of inflammatory markers will predict greater antidepressant response to minocycline.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • One hundred and twenty male or female outpatients between 18 and 65 years of age, who meet DSM-IV-TR criteria for BD (type I or II) and for a current major depressive episode will be recruited. The depressive syndrome must have been present for at least 4 weeks and the minimum threshold for depression severity will be set at a 17-item HAM-D score >10. Subjects will provide written informed consent as approved by the Western Institutional Review Board.

Exclusion Criteria:

  1. inability to provide informed consent;
  2. age of onset of BD>40 years;
  3. serious risk of suicide;
  4. current delusions or hallucinations sufficient to interfere with the capacity to provide informed consent;
  5. current manic symptoms [depressed BD patients with concurrent manic symptoms have been found to be more likely to experience adverse reactions in antidepressant treatment trials (23)];
  6. medical illness including as hepatic impairment, renal dysfunction, bleeding diatheses (e.g., hemophilia), known cerebrovascular disease or heart disease, hypertension that is inadequately controlled by medication, or known peptic ulcer disease;
  7. abuse of drugs or alcohol within the preceding 6 months, or substance dependence within the last 5 years;
  8. daily alcoholic beverage consumption equivalent to >3 oz of alcohol;
  9. asthma or known allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs;
  10. current use of drugs that could increase the risks associated with aspirin or minocycline administration, namely other antibiotic medications, other NSAIDs or anticoagulants (e.g., warfarin), acetazolamide, or methotrexate;
  11. known HIV or other chronic infection including, but not limited to viral hepatitis.
  12. Pregnant or nursing women, and women who are attempting to conceive during the 8 week study period, will also be excluded.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01429272

United States, Kansas
University of Kansas Medical Center Research Institute
Wichita, Kansas, United States, 67207
United States, Oklahoma
University of Oklahoma Department of Psychiatry
Tulsa, Oklahoma, United States, 74135
Laureate Institute for Brain Research
Tulsa, Oklahoma, United States, 74136-3326
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
Stanley Medical Research Institute
University of Oklahoma
Principal Investigator: Sheldon Preskorn, MD Laureate Institute for Brain Research, Inc.
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Laureate Institute for Brain Research, Inc. Identifier: NCT01429272     History of Changes
Other Study ID Numbers: LIBR 2011-002
Study First Received: September 2, 2011
Last Updated: October 28, 2015

Keywords provided by Laureate Institute for Brain Research, Inc.:
Bipolar Disorder

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents processed this record on September 20, 2017